REBOA in Nontraumatic OHCA (REBOA)

March 20, 2024 updated by: Dong Keon Lee, Seoul National University Hospital

Effect Of Resuscitative Endovascular Balloon Occlusion of the Aorta in Non-Traumatic Out-of-Hospital Cardiac Arrest (REBOA); A Multinational, Multicenter Randomized Controlled Trial

The investigators propose a multicenter randomized controlled trial in South Korea and Taiwan to observe the clinical effects of REBOA on nontraumatic out-of-hospital-cardiac-arrest (OHCA) patients. While REBOA has been traditionally used in trauma for hemorrhage control, it has also shown promising results in nontraumatic cardiac arrests by rerouting circulation to increase perfusion in the coronary and brain.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nontraumatic OHCA patients arriving at the 2 participating hospitals between the ages of 20 to 80 will be eligible. If the patient meets the enrollment criteria, he/she will be randomized into the control group (treatment with conventional ACLS according to the 2020 AHA guideline) or the REBOA group (ACLS according to the 2020 AHA guideline with REBOA application). A sheath catheter is inserted with ultrasound guidance to gain access to the common femoral artery in both groups. This is followed by insertion of the REBOA catheter, if the patient is allocated into the intervention group. The aortic balloon is inflated. If ROSC is achieved, the balloon is deflated slowly. Patients who achieve ROSC will receive post cardiac arrest management according to the 2020 AHA guideline.

Study Type

Interventional

Enrollment (Estimated)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National Univeristy Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult nontraumatic OHCA
  • Witnessed arrest
  • Arrival at ER from 9AM to 5PM (in each country)

Exclusion Criteria:

  1. age below 20 years old or over 80 years old,
  2. traumatic cardiac arrest,
  3. those with unwitnessed cardiac arrest,
  4. pregnant patients,
  5. patients who have already achieved ROSC upon arrival at the emergency department
  6. pre-cardiac arrest cerebral performance category of 3-4
  7. those showing evidence of cardiac arrest due to bleeding (such as gastrointestinal bleeding)
  8. those suspected of having aortic disease, such as dissection, intramural hematoma, or aneurysm, by bedside ultrasound performed immediately after ED arrival or have a previous history of aortic disease
  9. whose legal representative has requested termination of resuscitation efforts before study enrollment
  10. declared dead at scene before randomization
  11. Patients who meet the criteria for extracorporeal cardiopulmonary resuscitation (ECPR), and therefore the decision is made to perform ECPR, will not be enrolled. The ECPR criteria applies when all of the following criteria are met: pre-cardiac arrest CPC of 1-2, witnessed cardiac arrest with bystander CPR, ages between 20-70, initial shockable rhythm, ECMO pump-on available within 60 minutes of onset of cardiac arrest, and patients without end-stage diseases such as cancer, liver cirrhosis, or end-stage renal failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Patients allocated to this arm receives conventional resuscitative measures according to the 2020 AHA CPR Guidelines.
Experimental: REBOA
After enrollment and randomization, patients allocated to this arm receives REBOA in addition to conventional ACLS according to the 2020 AHA CPR guidelines. The common femoral artery is accessed with ultrasound guidance. A sheath catheter is inserted, followed by a REBOA catheter. The REBOA is ballooned with 20cc of normal saline or until resistance is felt.
Device: REBOA
Resuscitative endovascular balloon occlusion of the aorta (REBOA)is a device composed of a catheter attached to an inflatable balloon. It is inserted through the common femoral artery and guided to the thoracic aorta.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved ROSC (return of spontaneous circulation)
Time Frame: 24 hours
Number of patients who achieves ROSC regardless of sustained time
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved Sustained ROSC
Time Frame: 24 hours
Number of participants who achieves sustained ROSC (ROSC maintained more than 20 minutes)
24 hours
Survival to Admission
Time Frame: 48 hours
Whether patients who achieve sustained ROSC survives until admission
48 hours
Survival to Discharge
Time Frame: 30 days
Whether patients survive until hospital discharge.
30 days
Neurological Outcome
Time Frame: 1 month, 3 months, 6 months since ROSC
The cerebral performance category (CPC) and modified Rankin Score (mRS) of each patient at 28 days, 3 months, and 6 months after achieving ROSC. CPC is measured on a scale of 1 to 5, with 1 being the best neurological performance, and 5 indicating brain death. MRS is measured on a scale of 0 to 6, with 0 indicating no neurological deficit, and 6 indicating death.
1 month, 3 months, 6 months since ROSC
Changes in Arterial Blood Pressure
Time Frame: ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.
Arterial blood pressure measured before and after REBOA inflation in the experimental group. Both systolic and diastolic pressures will be used.
ABP 2 minutes and 1 minute before REBOA insertion, ABP 1 minute / 2 minutes / 4 minutes / 10 minutes after REBOA insertion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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